PURPOSE: To compare the intensity of posterior capsule opacification (PCO) 3 years after implantation of 2 different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs). DESIGN: Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. METHODS:One hundred patients with bilateral age-related cataract (200 eyes) had standard cataract surgery with implantation of an iMics1 NY-60 IOL (Hoya Corp) in one eye and an AcrySof SN60WF IOL (Alcon Laboratories) in the other eye. Follow-up examinations were performed at 1 week and 3 years. Digital retroillumination images were obtained of each eye. The main outcome measure was PCO score (scale, 0 to 10) assessed subjectively at the slit lamp and objectively using automated image analysis software (Automated Quantification of After-Cataract) 3 years after surgery. RESULTS: The objective PCO score (mean ± standard deviation) was 3.0 ± 2.0 for the iMics1 NY-60 IOL and 1.9 ± 1.4 for the AcrySof SN60WF IOL (P < .001). Three years after surgery, 35.6% of patients underwent a neodymium:yttrium-aluminum-garnet capsulotomy in the iMics1 NY-60 eye and 13.7% underwent a capsulotomy in the AcrySof SN60WF eye (P = .001). There was no statistically significant difference in best-corrected visual acuity, rhexis-IOL overlap, capsular folds, or anterior capsule opacification. Glistening formations were found in no iMics1 NY-60 IOLs, but in 97% of the AcrySof SN60WF IOLs. CONCLUSIONS: Comparison of 2 sharp-edged single-piece IOLs of similar design and hydrophobic acrylic material indicated a statistically significant difference in PCO and neodymium:yttrium-aluminum-garnet capsulotomyrate 3 years after surgery.
RCT Entities:
PURPOSE: To compare the intensity of posterior capsule opacification (PCO) 3 years after implantation of 2 different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs). DESIGN: Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. METHODS: One hundred patients with bilateral age-related cataract (200 eyes) had standard cataract surgery with implantation of an iMics1 NY-60 IOL (Hoya Corp) in one eye and an AcrySof SN60WF IOL (Alcon Laboratories) in the other eye. Follow-up examinations were performed at 1 week and 3 years. Digital retroillumination images were obtained of each eye. The main outcome measure was PCO score (scale, 0 to 10) assessed subjectively at the slit lamp and objectively using automated image analysis software (Automated Quantification of After-Cataract) 3 years after surgery. RESULTS: The objective PCO score (mean ± standard deviation) was 3.0 ± 2.0 for the iMics1 NY-60 IOL and 1.9 ± 1.4 for the AcrySof SN60WF IOL (P < .001). Three years after surgery, 35.6% of patients underwent a neodymium:yttrium-aluminum-garnet capsulotomy in the iMics1 NY-60 eye and 13.7% underwent a capsulotomy in the AcrySof SN60WF eye (P = .001). There was no statistically significant difference in best-corrected visual acuity, rhexis-IOL overlap, capsular folds, or anterior capsule opacification. Glistening formations were found in no iMics1 NY-60 IOLs, but in 97% of the AcrySof SN60WF IOLs. CONCLUSIONS: Comparison of 2 sharp-edged single-piece IOLs of similar design and hydrophobic acrylic material indicated a statistically significant difference in PCO and neodymium:yttrium-aluminum-garnet capsulotomy rate 3 years after surgery.